Esika Silk Skin

Dosage form: powder
Ingredients: OCTINOXATE 0.02g in 1g, TITANIUM DIOXIDE 0.044g in 1g
Labeler: Ventura International LTD
NDC Code: 14783-302

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

─ôsika

Drug Facts

Active Ingredients

Octinoxate (2%), Titanium Dioxide (4.43%)

Purpose

Sunscreen

Uses
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides minimum protection against sunburn

Warnings
  • For external use only

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if rash and irritation develops and lasts.

  • Children under 6 months of age: ask a doctor.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Apply smootly every morning before sun exposure and as needed.
  • Sun protection product.

Other information
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Talc, zea mays starch( zea mays (corn) starch), calcium carbonate, silica, zinc stearate, paraffinum liquidum (mineral oil), CI 77019 (mica), dimethicone/methicone copolymer, octyldodecanol, alumina, methylparaben, propylparaben, microcristallina cera (microcrystalline wax), petrolatum, phospholipids, polyethylene, cholesterol, polyglyceryl-2 dipolyhydroxystearate, copernicia cerifera cera (copernicia cerifera (carnauba) wax), candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl glucoside, cetearyl alcohol, glycosphingolipids. May contain: CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 15 g Carton

─ôsika

Silk Skin
Face Powder SPF 9

15 g e (.53 oz.)

ESIKA   SILK SKIN
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-302
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.02 g  in 1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.044 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
TALC 
STARCH, CORN 
CALCIUM CARBONATE 
SILICON DIOXIDE 
ZINC STEARATE 
MINERAL OIL 
MICA 
OCTYLDODECANOL 
ALUMINUM OXIDE 
METHYLPARABEN 
PROPYLPARABEN 
MICROCRYSTALLINE WAX 
PETROLATUM 
CHOLESTEROL 
CARNAUBA WAX 
CANDELILLA WAX 
YELLOW WAX 
CETEARYL GLUCOSIDE 
CETOSTEARYL ALCOHOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:14783-302-021 JAR (JAR) in 1 BOX
1NDC:14783-302-0115 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2011
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIOperations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 05/2011
 
Ventura International LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)